Objective: Given the often prominent and
persistent nature of hyperhidrosis in social
anxiety disorder (SAD), to compare botulinum toxin
type A to placebo for generalized SAD with hyperhidrosis, in combination with paroxetine.

Method: Adults with severe axillary
hyperhidrosis who met DSM-IV criteria for
generalized SAD were randomly assigned to receive
1-time, bilateral, intradermal injections with either
botulinum toxin type A or placebo (50 units/axilla).
All subjects also received 8 weeks of open-label treatment with paroxetine. The primary
outcome measure was the Hyperhidrosis Disease
Severity Scale (HDSS). Secondary measures included
the Hyperhidrosis Impact Questionnaire, Brief
Social Phobia Scale, Liebowitz Social Anxiety
Scale, Social Phobia Inventory, and Sheehan
Disability Scale. Enrollment occurred from June 2002
to July 2004.

Results: Forty subjects were randomly
assigned to treatment and included in the
analyses. Response rates were 75% (15/20) for
botulinum toxin type A versus 15% (3/20) for placebo on
the HDSS (p < .001). Botulinum toxin type A produced significantly more improvement in
many daily activities that had been limited (p < .01),
as well as greater improvement in work and social functioning and in overall disability
(p < .05). Botulinum toxin type A was well tolerated, as
was paroxetine.

Conclusion: Botulinum toxin is effective
in reducing hyperhidrosis disability and
limitations in everyday activities when given in
association with paroxetine to subjects with SAD. While
further assessment of botulinum toxin type A in SAD is recommended, including a trial of
botulinum toxin type A monotherapy, the results
suggest that this well-tolerated treatment
deserves further consideration in overall management
of SAD accompanied by hyperhidrosis.